Alerta
- 22 outubro 2024
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STF rules on Theme No. 1234 and defines criteria for the supply of non-standardized medicines in the SUS in lawsuits
On September 13, 2024, the Federal Supreme Court (STF) concluded the virtual trial of Extraordinary Appeal No. 1366243 (Theme 1234), which discussed, among other matters, the passive legitimacy of the Union and the jurisdiction of the Federal Court in lawsuits that deal with the supply of non-standardized medicines in the Unified Health System (SUS).
The case originated in a decision handed down by the Court of Justice of Santa Catarina (TJSC), which ordered the state government to supply medicines not incorporated into the SUS to a patient with refractory epilepsy. At the time, the government of Santa Catarina appealed to transfer the action to the Federal Court and include the Union as jointly liable for the supply, but the request was denied.
The discussion deepened the division of responsibilities between the federative entities for the cost of medicines not incorporated into the SUS in cases of judicialization. In April 2023, Minister Gilmar Mendes, the rapporteur of the case, suspended all ongoing appeals in the STF and STJ related to the topic and created a special committee to debate the issue with representatives of the federative entities and civil society.
The Union, states, Federal District and municipalities reached three agreements on the definition of the jurisdiction of the Federal Court and the reimbursement to be made by the Union in lawsuits over non-incorporated medicines and the approvals which were under discussion during the trial of RE 1366243.
In the virtual plenary session, the Ministers voted to approve partially the agreements under the terms presented by the Rapporteur’s vote, which, among others, include the following provisions:
- Claims related to medicines not incorporated into the SUS will be processed in the Federal Court when the annual treatment value is equal to or greater than 210 (two hundred and ten) minimum wages. In these cases, the medicines will be fully paid for by the Union.
- Non-incorporated medicines are those that are not included in the SUS public policy, medicines provided for in official clinical protocols for other purposes, medicines not registered with Anvisa and off-label medicines without a clinical protocol or that are not included in the basic component lists).
- When the annual unit cost of the medication is between 7 (seven) and 210 (two hundred and ten) minimum wages, the cases will remain in the State Court. The Union must reimburse 65% of the expenses resulting from convictions of the states and municipalities.
- Unincorporated oncological medications will have a reimbursement percentage of 80% by the Union, in lawsuits filed until 06/10/2024, if the cost is higher than 7 (seven) minimum wages. The Federal Court maintains jurisdiction over lawsuits demanding the supply of medicines not registered with Anvisa, which must necessarily be filed against the Union.
The decision also provides for:
- the creation of a national platform to gather all information on demands for medicines, to facilitate the management and monitoring of cases and the definition of responsibilities between the Union, states and municipalities, and
- the ongoing responsibility of the health service to which the professional prescribing the medicine not incorporated into the SUS is linked for the clinical monitoring of the patient, who must periodically present an updated report on their clinical condition, detailed information on the progress of the treatment and any relevant changes in the therapeutic plan.
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